Randomized Phase II Study of Gemcitabine Plus Radiotherapy Versus Gemcitabine, 5-Fluorouracil, and Cisplatin Followed by Radiotherapy and 5-Fluorouracil for Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma

• Type of Material: Article
• Authors: Jerome Landry, Emory University; Paul J. Catalano, Harvard University; Charles Staley, Emory University; Wayne Harris, Emory University; John Hoffman, Fox Chase Cancer Center; Mark Talamonti, Northwestern University; Natalie Xu, Emory University; Harry Cooper, Fox Chase Cancer Center; Al B. Benson, III, Northwestern University
• Language: English
• Date: 2010-06-01
• Publisher: Wiley: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2010 Wiley-Liss, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1002/jso.21527
• Title of Journal or Parent Work: Journal of Surgical Oncology
• ISSN: 0022-4790
• Volume: 101
• Issue: 7
• Start Page: 587
• End Page: 592
• Grant/Funding Information: Conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA27525, CA07190, CA21076, CA49957, CA17145 and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services.
• Keywords: TRIAL; INTRAOPERATIVE RADIATION-THERAPY; Science & Technology; RESECTION; HEAD; gemcitabine; SOLID TUMORS; Life Sciences & Biomedicine; PREOPERATIVE CHEMORADIATION PANCREATICODUODENECTOMY; TWICE-WEEKLY GEMCITABINE; FULL-DOSE GEMCITABINE; pancreatic cancer; Surgery; radiotherapy; CANCER; Oncology; CONCURRENT RADIATION
• Research Categories: Biology, Biostatistics; Health Sciences, Medicine and Surgery; Health Sciences, Oncology

Abstract

Purpose: A randomized phase II trial (E1200) was designed to assess toxicities and surgical resection rates in two neoadjuvant gemcitabine-based chemoradiation regimens in patients with borderline resectable pancreatic cancer. The trial was terminated early due to poor accrual. Patients and Methods: Patients with borderline resectable adenocarcinomas of the pancreas were enrolled. Arm A patients (n = 10) received gemcitabine 500 mg/m2 IV weekly for 6 weeks, with radiation to 50.4 Gy followed by surgical resection. Arm B patients (n = 11) received preoperative gemcitabine 175 mg/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 weekly x 3 for five cycles. Results: Three patients in arm A, and two patients in arm B were resected. Hematologic toxicity was comparable between the two arms except more patients in arm B developed grade 3 or 4 thrombocytopenia than those in arm A. Arm B had fewer grade 1-2 GI toxicities although more patients (45%) experienced grade 3-4 GI toxicity. Conclusions: This phase II trial showed that both regimens were tolerable, and resectability and survival were comparable to previous studies.